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BackgroundRecruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. ObjectiveThe primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. MethodsWe applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app–based intervention for people diagnosed with schizophrenia. ResultsRecruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. ConclusionsResearchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

BackgroundRelapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. ObjectiveThis study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. MethodsWe will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. ResultsRecruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. ConclusionsThe knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID)DERR1-10.2196/15058

BackgroundRelapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. ObjectiveThis study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. MethodsThe overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. ResultsThe results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. ConclusionsThe findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. Trial RegistrationISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID)DERR1-10.2196/15634

Background: Personal recovery is a persisting concern for people with psychotic disorders. Accordingly, mental health services have adopted frameworks of personal recovery, prioritizing adaptation to psychosis alongside symptom remission. Group acceptance and commitment therapy (ACT) for psychosis aims to promote personal recovery alongside improved mood and quality of life. Aims: The objectives of this uncontrolled, prospective pilot study were to determine whether 'Recovery ACT' groups for adults are a feasible, acceptable and safe program within public mental health services, and assess effectiveness through measuring changes in personal recovery, wellbeing, and psychological flexibility. Method: Program feasibility, acceptability and safety indicators were collected from referred consumers (n =105). Adults (n =80) diagnosed with psychotic disorders participated in an evaluation of 'Recovery ACT' groups in Australian community public mental health services. Participants completed pre- and post-group measures assessing personal recovery, wellbeing, and psychological flexibility. Results: Of 101 group enrollees, 78.2% attended at least one group session (n =79); 73.8% attended three or more, suggesting feasibility. Eighty of 91 first-time attendees participated in the evaluation. Based on completer analyses (n =39), participants' personal recovery and wellbeing increased post-group. Outcome changes correlated with the linear combination of psychological flexibility measures. Conclusions: 'Recovery ACT' groups are feasible, acceptable and safe in Australian public mental health services. 'Recovery ACT' may improve personal recovery, wellbeing, and psychological flexibility. Uncontrolled study design, completer analyses, and program discontinuation rates limit conclusions. [ABSTRACT FROM AUTHOR]

Background: Prevention and Recovery Care services are residential sub-acute services in Victoria, Australia, guided by a commitment to recovery-oriented practice. The evidence regarding the effectiveness of this service model is limited, largely relying on small, localised evaluations. This study involved a state-wide investigation into the personal recovery, perceived needs for care, well-being and quality-of-life outcomes experienced by Prevention and Recovery Care services' consumers. Methods: A longitudinal cohort design examined the trajectory of self-reported personal recovery and other outcomes for consumers in 19 Victorian Prevention and Recovery Care services over 4 time points (T1 – 1 week after admission; T2 – within 1 week of discharge; T3 – 6 months after discharge; T4 – 12 months after discharge). T2–T4 time frames were extended by approximately 3 weeks due to recruitment challenges. The Questionnaire about the Process of Recovery was the primary outcome measure. Results: At T1, 298 consumers were recruited. By T4, 114 remained in the study. Participants scored higher on the Questionnaire about the Process of Recovery at all three time points after T1. There were also sustained improvements on all secondary outcome measures. Improvements were then sustained at each subsequent post-intervention time point. Community inclusion and having needs for care met also improved. Conclusion: The findings provide a consistent picture of benefits for consumers using Prevention and Recovery Care services, with significant improvement in personal recovery, quality of life, mental health and well-being following an admission to a Prevention and Recovery Care service. Further attention needs to be given to how to sustain the gains made through a Prevention and Recovery Care service admission in the long term. [ABSTRACT FROM AUTHOR]

Fear of relapse into psychosis is an independent risk factor for future relapse events, indicating its importance as a novel intervention target. Twenty-five participants responded to daily ecological momentary assessment prompts assessing common early warning signs of relapse and self-reported positive experiences like feeling supported by others. We conducted multilevel vector auto-regression using common symptoms assessed in early warning signs monitoring relapse prevention while controlling for positive self-reported experiences like feeling supported by others to estimate three networks (to explore concurrent, temporal and overall relationships). Reporting fear of relapse was positively associated (within the same cross-sectional time window) with hearing voices, alongside anxiety, negative affect and sleep change. Fear of relapse appeared to predict anxiety, negative affect and greater fear of relapse on the next consecutive day. However, none of the typical early warning signs predicted fear of relapse within the temporal window, and the observed relationships were small. Early warning signs appeared to be poor predictors of experiencing fear of relapse in this study. Fear of relapse predicts later anxiety and negative affect and may be a valuable intervention target within the daily life of people diagnosed with schizophrenia. [ABSTRACT FROM AUTHOR]

Digital technologies enable the dissemination of multimedia resources to support adults with serious mental illness in their self-management and personal recovery. However, delivery needs to accommodate engagement and accessibility challenges. We examined how a digital resource, designed for mental health workers and consumers to use together in session, would be used in routine practice. Thirty consumers and their workers participated. The web-based resource, Self-Management And Recovery Technology (SMART), was available to use within and between sessions, for a 6-month period. Workers initiated in-session use where relevant. Feasibility was explored via uptake and usage data; and acceptability and impact via questionnaires. A pre-post design assessed recovery outcomes for consumers and relationship outcomes for consumers and workers. In participating mental health practitioner-consumer dyads, consumers gave strong acceptability ratings, and reported improved working relationships. However, the resource was typically used in one-third or fewer appointments, with consumers expressing a desire for greater in-session use. Improvements in self-rated personal recovery were not observed, possibly contributed to by low usage. In-session use was found helpful by consumers but may be constrained by other demands in mental health care delivery: collaborative use may require dedicated staff time or more formal implementation. [ABSTRACT FROM AUTHOR]

: Psychosocial, evidence-based interventions (EBI) may support personal recovery from psychosis; however, little is known about their implementation. : This paper describes the adaptation, implementation, and evaluation of a psychosocial EBI, group Acceptance and Commitment Therapy (ACT), designed to support personal recovery of people living with psychosis who are accessing Australian public mental health services. We outline the process of adapting and implementing a group program, and present results of a qualitative analysis of facilitator experiences of the first 6 groups conducted involving 69 participants. Eight facilitators participated in an expert-led reflective interview developed to gather feedback in five domains. : A thematic analysis of transcribed audio-recorded interviews elicited nine themes that indicated: local adaptations facilitated participant learning; targeted efforts to engage all stakeholders were successful; clinical supervision and research support by local experts enabled program implementation and evaluation; implementation offered facilitators personal rewards; and a need for further engagement of organisational support. : This paper identifies enablers of successful adaptation and implementation of ACT groups for recovery from psychosis, an EBI in public mental health services. Study limitations include the risk of a self-serving reporting bias and the absence of lived experience expertise in group facilitation and evaluation. [ABSTRACT FROM AUTHOR]

Acceptance and mindfulness methods that emphasise the acceptance rather than control of symptoms are becoming more central to behavioural and cognitive therapies. Acceptance and Commitment Therapy (ACT) is the most developed of these methods; recent applications of ACT to psychosis suggest it to be a promising therapeutic approach. However, investigation of the mechanisms of therapy within this domain is difficult because there are no acceptance-based measures available specifically for psychotic symptoms. This paper describes the preliminary evaluation of a self-report instrument designed to assess acceptance-based attitudes and actions in relation to auditory and command hallucinations. Following initial scale development, a 56-item version of the Voices Acceptance and Action Scale (VAAS) was administered to 43 participants with command hallucinations as part of their baseline assessment in a larger trial. Measures of symptoms, quality of life, and depression were also administered. The scale was examined for reliability using corrected item total statistics. Based on this method, 31 items were retained. Internal consistency and test-retest reliability for the 31-item VAAS were acceptable. Subsequent examination of construct validity showed the VAAS to correlate significantly in the expected directions with depression, quality of life, and coping with command hallucinations. It also discriminated compliance from non-compliance with harmful command hallucinations. Although these results are preliminary and subject to a number of limitations, the VAAS shows promise as a useful aid in the assessment of the psychological impact of voices. Keywords: auditory hallucinations: command hallucinations; psychosis; acceptance and commitment therapy (ACT); instrument